BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2894119 · Received December 27, 2012

    Report

    Report Number
    2023826-2012-01018
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    October 2, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 11.5 MM ICM115V4 IMPLANTABLE COLLAMER LENS IN PATIENT'S LEFT EYE ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO LOW VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. PATIENT'S LAST VISIT ON (B)(6) 2012, UCVA WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention